UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008093
Receipt number R000008987
Scientific Title Phase 1 Clinical Trial of intra-thoracic administration of Zoredronic Acid in Subjects with Unresectable Malignant Pleural Mesothelioma
Date of disclosure of the study information 2012/06/04
Last modified on 2019/01/31 17:08:01

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Basic information

Public title

Phase 1 Clinical Trial of intra-thoracic administration of Zoredronic Acid in Subjects with Unresectable Malignant Pleural Mesothelioma

Acronym

Phase 1 Trial of Zoredronic Acid in Malignant Pleural Mesothelioma

Scientific Title

Phase 1 Clinical Trial of intra-thoracic administration of Zoredronic Acid in Subjects with Unresectable Malignant Pleural Mesothelioma

Scientific Title:Acronym

Phase 1 Trial of Zoredronic Acid in Malignant Pleural Mesothelioma

Region

Japan


Condition

Condition

Malignant Pleural Mesothelioma

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

o establish the safety of intra-thoracic administration of Zoredronic Acid and to guide decision making for the effective dose

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

Evaluation of the incidence of the adverse effect and dose limiting dose(DLT)

Key secondary outcomes

Anti-tumor effect (Response to the treatment)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Initial dose of 0.4mg of Zoredronic acid will be administered by injection into thoracic cavity. Thereafter, patients will be observed for at least two weeks to evaluate the adverse effects. Transition to the next cohort will be decided following the evaluation of the development of DLT. The dose will be gradually increased every three subjects from 0.4mg to 1mg, 4mg, 8mg, 12mg and 16mg respectively.Repeat injections for the same patient at the same dose are acceptable.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with histologically or
cytologically documented malignant
pleural mesothelioma
Unresectable case(including recurrent case of post-operation)
Patients refractory to chemotherapy,
or those relapsed after therapies.
Patients who reject chemotherapy will
be also included.
ECOG Performance status 0 to 2
Life expectancy must be longer than 3 month from
the entry.
Patients who are free of marked
failure of major organ function, more
over the following criteria must be
satisfied in laboratory tests. WBC >=3000/mm3, neutrophil>=1500 /mm3, Hgb>=
8.0 g/dl, Plt >=100.000 /mm3, AST/ALT<=
100 IU/L, T-Bil<=1.5 mg/dl, Cre<=1.5
mg/dl Ccr >=60 ml/min , PaO2>= 60 mmHg or>=90% by pulse oxymetry
Informed consent must be obtained

Key exclusion criteria

Patient with active multiple primary
cancer (synchronous multiple primary
cancer and invasive cancer of other
organs)
Patient with symptomatic brain
metastasis requiring any treatments
Patient underwent thoracic irradiation
therapy or pleurodesis (within a month).
Patient with interstitial pneumonia,
confirmed by clinical examination or
by chest CT scan
Patients with history of myocardial
infarction (MI) in recent 6 month, or
those with any risk of MI recurrence.
Patient with other severe medical
complications.
Patient with history of drug-related
allergy to zoredronic acid or other
bisphosphonate or those with AEs over
Grade 3 in CTCAE.
Patient with stomatognathic disease
(pulpitis, gingivitis,etc) requiring
invasive (surgical) treatment.
Patient who received chemotherapy for
mesothelioma, or those participated
other clinical trial for unapproved
drug with in a month.
Difficult to participate in the trial
because of psychiatric disorder or
psychiatric symptoms
Pregnant or lactating woman.
Ineligible to the trial based on
decision of an investigator, such as
poor compliance to follow up in the
clinical course.

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Tada

Organization

Chiba University Hospital

Division name

Department of Respirology

Zip code


Address

260-5670 1-8-1 Inohana Chuo-ku Chiba, Chiba prefecture, Japan

TEL

81432227171

Email

ytada@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuji Tada

Organization

Chiba University Hospital

Division name

Department of Respirology

Zip code


Address

260-5670 1-8-1 Inohana Chuo-ku Chiba, Chiba prefecture, Japan

TEL

81432227171

Homepage URL

http://www.m.chiba-u.ac.jp/class/respir/index.html

Email

ytada25@yahoo.co.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Chiba Cancer Center
Toho University Omori Medical Center
Tokyo Women's Medical University Yachiyo Medical Center

Name of secondary funder(s)

none


IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

千葉大学医学部附属病院(千葉県) Chiba University Hospital


Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 04 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 03 Month 26 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 01 Day

Last follow-up date

2018 Year 12 Month 24 Day

Date of closure to data entry

2018 Year 12 Month 24 Day

Date trial data considered complete

2018 Year 12 Month 24 Day

Date analysis concluded

2018 Year 12 Month 24 Day


Other

Other related information



Management information

Registered date

2012 Year 06 Month 04 Day

Last modified on

2019 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008987


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name